Orca1

FDA inspection

Cardiac Designs Inc.: FDA inspection ending Jul 2, 2015

FDA inspection 932644 · Official Action Indicated (OAI) · Round Rock, TX

Key facts

Inspection ID 932644
Firm Cardiac Designs Inc.
FEI number 3010665082
Address 1104 S Mays St Ste 219
City Round Rock
State TX
ZIP 78664-6769
Fiscal year 2015
Inspection end date Jul 2, 2015
Classification Official Action Indicated (OAI)
Project area Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices
Product type Devices
Warning letter 476728

At a glance

  • None Citations
  • 1–9 Posted citations
  • Yes Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

Other inspections at this establishment

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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